August 03, 2015

NIH Researchers: Changes That Involve Human Subjects in Active Awards

Current National Institutes of Health policy requires prior approval from the NIH awarding Institute/Center (IC) for a change in scope. One of the potential indicators of a change in scope is a change from the approved involvement of human subjects.

Such changes include:

1. An addition or change to the study design/protocol that would result in the need to change the overall human subjects’ designation or clinical trial designation of the grant:
  • From non-human subjects research to human subjects research (exempt or non-exempt);
  • From exempt to non-exempt human subjects research; or
  • From “No Clinical Trial” to “Includes a Clinical Trial”; see revised NIH definition of clinical trial
2. The new inclusion of subject populations that are covered by additional regulatory protections under 45 CFR 46 subparts B, C or D (pregnant women, human fetuses, and neonates; prisoners; or children)

3. Any change to the study protocol that would result in an overall increase in risk level for subjects, including physical, psychological, financial, legal or other risks.

4. New information that comes to light after a study is underway which indicates a higher level of risk to participants than previously recognized for a study intervention, procedure, or pharmacological treatment.

Process for Submitting Prior Approval Requests

Individuals designated as an award’s Program Director/Principal Investigator are strongly encouraged to discuss any potential changes in human subjects’ research under consideration with the Grants Management Officer (GMO) and Program Official at the funding IC to determine if the proposed changes will require prior approval as a change from the approved involvement of human subjects.

Prior approval requests must be submitted in writing (including submission by email) by the Authorized Organization Representative to the GMO of the funding IC no later than 30 days before the proposed change.

Although proposed changes may be addressed in the annual progress report, the formal prior approval request must be submitted as a separate request to the funding IC, prior to initiating the new human subjects’ activities.

For more information, including what required documentation should be included in the Prior Approval Request, see Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval: Updated Notice (NOT-OD-15-128).